The following data is part of a premarket notification filed by Syva Co. with the FDA for Collection Kit Chlamydia Trachomatis.
| Device ID | K832079 |
| 510k Number | K832079 |
| Device Name: | COLLECTION KIT CHLAMYDIA TRACHOMATIS |
| Classification | Device, Specimen Collection |
| Applicant | SYVA CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LIO |
| CFR Regulation Number | 866.2900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-06-28 |
| Decision Date | 1983-09-29 |